MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)


Device Classification Name

incubator, neonatal

510(k) Number K072512
Device Name MODIFICATION TO: OHMEDA MEDICAL GIRAFFE INCUBATOR (GIRAFFE AND PANDA UNINTERRUPTIBLE POWER SUPPLY)
Applicant
DATEX-OHMEDA, INC.
8880 gorman road
laurel, 
MD 
20723

Applicant Contact agata smieja
Correspondent
DATEX-OHMEDA, INC.
8880 gorman road
laurel, 
MD 
20723

Correspodent Contact agata smieja
Regulation Number 880.5400
Classification Product Code
FMZ  
Date Received 09/06/2007
Decision Date 10/03/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No